Different Effects of Delayed Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women

February 19, 2023 updated by: Second Affiliated Hospital of Wenzhou Medical University

Different Effects of Delayed Cord Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women

Objective:The aim of this study was to investigate the relationship between delayed cord clamping and neonatal bilirubin levels in pregnant women with intrahepatic cholestasis of pregnancy.

Method:This observational prospective cohort study included a total of 200 pregnant women at 37-40 gestational weeks. Among them, 100 pregnant women with intrahepatic cholestasis of pregnancy were divided into 50 cases of immediate cord clamping group （ICC in pregnant women with ICP）and 50 cases of delayed cord clamping group（DCC in pregnant women with ICP）, and 100 normal pregnant women were also divided into 50 cases of immediate cord clamping group （ICC in normal pregnant women）and 50 cases of delayed cord clamping group（DCC in normal pregnant women）. The bilirubin levels of neonates in each group were compared.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Recruiting
        • department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Study Population

pregnant women

Description

Inclusion Criteria:

  1. The pregnant woman is born at a gestational age of 37-40 weeks;
  2. The pregnant woman has a single child;
  3. Regular obstetric examination durinv pregnancy with complete obstetric examination data was diagnosed as intrahepatic cholestasis of pregnancy(ICP).

Exclusion Criteria:

  1. Pregnancy complicated with medical and surgical diseases, such as thyroiddysfunction and chronic hypertension;
  2. Insufficiency of vital organ function or complicated tumor;
  3. Pregnant women with other pregnancy complications besides ICP, such as preeclampsia, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ICC in pregnant women with ICP
Immediate cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy
Other: clamp time of umbilical
The umbilical cord was clamped immediately or late for more than 30s
Experimental: DCC in pregnant women with ICP
Delayed cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy
Other: clamp time of umbilical
The umbilical cord was clamped immediately or late for more than 30s
Other: ICC in normal pregnant women
Immediate cord clamping group in normal pregnant women
Other: clamp time of umbilical
The umbilical cord was clamped immediately or late for more than 30s
Experimental: DCC in normal pregnant women
Delayed cord clamping group in normal pregnant women
Other: clamp time of umbilical
The umbilical cord was clamped immediately or late for more than 30s

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the neonatal bilirubin values
Time Frame: 2-4 days after birth
the neonatal bilirubin values
2-4 days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

November 28, 2022

First Submitted That Met QC Criteria

November 28, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 19, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2022-07-206

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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